FDA Medical Device Recalls (openFDA)
W L Gore & Associates, Inc.: REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
- Recall number
- Z-0171-2022
- Recalling firm
- W L Gore & Associates, Inc.
- Product
- REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
- Status
- Open, Classified
- Initiated
- 2021-09-02
- Posted
- not on file
- Terminated
- not on file
- Reason
- Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
- Root cause
- Software change control
- Action
- Gore initiated distribution of "Urgent Medical Device Recall" Notification to affected consignees between the dates of September 2, 2021 - September 21, 2021. The customer communication was distributed via Email and UPS. In addition, to informing consignees about the recall, Gore asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. Return Authorization number can be found on the CUSTOMER RESPONSE FORM. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore3120@sedgwick.com within 3 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been used, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used devices on the CUSTOMER RESPONSE FORM and return to WLGore3120@sedgwick.com within 3 weeks of receipt of this letter. No further action is needed. 5. Please contact your local Gore field sales associate with any questions regarding this notice, and to coordinate the return and replacement of any unused affected devices. Additionally, you may also contact Gore Customer Service (Email: MPDCustomerCare@wlgore.com; or by phone (U.S. toll free: (800) 528-8763)). 6. In the event that an adverse event occurs: Any adverse event involving the GORE CARDIOFORM Septal Occluder should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com or contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364 Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Quantity
- 222 units
- Distribution
- US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
- Lot, serial or model codes
- serial numbers 22689696 through 23569078
- 510(k) numbers
- not on file
- PMA numbers
- ["P050006S044"]
- Product code
- MLV
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28